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Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory (DEEPBRAIN)

2026年4月28日 更新者:Monika Pupikova、Masaryk University

A study investigating the effects of non-invasive electrical stimulation of deep brain structures on working memory, attention, and executive functions involved in everyday activities. Currently, there is no effective treatment for impairments in these functions. The study will evaluate the effects of non-invasive electrical stimulation in both healthy older adults and individuals with mild impairment of these functions.

The study combines magnetic resonance imaging (MRI) with non-invasive brain stimulation targeting deep brain structures. Its aim is to improve understanding of the neural mechanisms underlying these cognitive functions and their impairments, as well as to explore the mechanisms of non-invasive brain stimulation for potential future therapeutic applications.

研究概览

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • normal cognitive performance as assessed by a cognitive screening for healthy subjects
  • possible or probable MCI-LB or with PD-MCI, collectively called MCI-LBD, described as: presence of PD , and level II criteria for MCI (i.e. based on comprehensive neuropsychological examination), or the level II criteria for MCI , and at least two of four core DLB features including parkinsonism, visual hallucinations, attention/cognitive function fluctuation, and REM sleep behavioral disorder, or at least 1 core clinical feature and 1 indicative biomarker (probable MCI-LB).

Exclusion Criteria:

  • Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:20 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (20 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (20 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
实验性的:60 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (60 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (60 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
假比较器:Sham striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with no low-frequency offset. The stimulation will be applied only shortly and turned off after ramp-up and ramp-down period.
A high-frequency tES without low-frequency offset. It will consist of two oscillatory high-frequency currents without any frequency shifts, which induces similar skin sensations as deep-tES and will be applied just for a ramp-up/ramp-down phases at the beginning of the stimulation and afterwards will be switched off.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
大体时间:During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)
The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
大体时间:During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)

次要结果测量

结果测量
措施说明
大体时间
Working memory performance - Reaction times
大体时间:During intervention (approx 10 minutes)
Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.
During intervention (approx 10 minutes)
Working memory parformance - Accuracy
大体时间:During intervention ( approximately 10 minutes)
Accuracy (measured as D-prime) of an N-back task between the real and sham stimulation condition in a cross-over design.
During intervention ( approximately 10 minutes)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (估计的)

2026年7月1日

研究完成 (估计的)

2026年7月1日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • NW25-04-00142

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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